The Raltegravir 60+ Study

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This is a phase I, open label, prospective, one phase pharmacokinetic and observational study.

Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing.

At baseline, subjects will switch antiretroviral therapy to:

tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus

raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.

Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken.

Following completion of this study, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.

full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus

Secondary Outcome Measures
:

cardiovascular disease markers [ Time Frame: 6 months ]

• To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.

Cerebral function [ Time Frame: 6 months ]

To investigate cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.

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Ages Eligible for Study:

60 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV-1 infected males or females

60 years of age or greater*

signed informed consent

willing to switch therapy as per study protocol

no previous exposure to raltegravir or HIV-1 integrase inhibitors

plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months

currently receiving a stable antiretroviral regimen with no antiretroviral drug switches for at least 3 months

subjects in good health upon medical history, physical exam, and laboratory testing

BMI above or equal to 18 and below 32

Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study.

Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance * 50% of total enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged between 60 and 64 recruited, only subjects aged 65 or over will be eligible.